Product and Industry News

Beta-Cath System With 60-mm Radiation Source Receives FDA Clearance Novoste Corp. has received FDA clearance to market its Beta-Cath System with a longer 60-mm radiation source. The 60-mm device is ideally suited to treat long, diffuse in-stent restenosis. Approval of the 60-mm device was based on the results of a 139 patient subset (RENO Long) of the 1,098-patient RENO (REgistry NOvoste) European registry trial. An analysis was performed on the RENO Long group and compared to a placebo control group selected from the Washington Radiation for In-Stent Restenosis Trials. Trial data demonstrated a 75 percent reduction in target vessel revascularization (TVR) rate (14.9 percent vs. 60.6 percent) and a 72 percent reduction in Major Adverse Cardiac Event (MACE) rate (17.9 percent vs. 64.9 percent) for the subset of patients receiving Sr-90 beta radiation compared to this placebo control group. The average lesion length for the RENO Long patient subset was 35.3 mm (site reported) compared to the average lesion length of 28.0 mm in the WRIST / LONG WRIST placebo control group. These results, presented last week at the American College of Cardiology meeting in Atlanta, Ga., supported the FDA approval for the Beta-Cath System with 60-mm radiation source. The Beta-Cath System with 60-mm radiation source train length will be especially useful for treatment of patients with diffuse, in-stent restenosis, Thomas D. Weldon, chairman and CEO, said in a statement. Typically, this patient subset has the worst clinical outcomes due to the complexity of their disease. Abbott Laboratories to Acquire Cardiovascular Stent Business of Biocompatibles International PLC Abbott Laboratories and Biocompatibles International plc announced that the companies have entered into a definitive agreement for Abbott to acquire the cardiovascular stent business of Biocompatibles. Under the terms of the agreement, Abbott will acquire the business for approximately $234.5 million in cash. The transaction is expected to be completed in the second quarter of 2002, subject to regulatory approvals and customary closing conditions. In 1999, Abbott and Biocompatibles signed a multi-year agreement for Abbott to exclusively distribute Biocompatibles’ BiodivYsioÂ® coated stents in the United States. The acquisition of Biocompatibles’ cardiovascular stent business enhances Abbott’s portfolio of marketed products and expands Abbott's presence outside the United States market for polymer-coated and, in the future, drug-coated stents. Through the transaction, Abbott acquires additional commercial infrastructure and marketing presence in Europe and secures access to Biocompatibles’ polymer chemistry research and development organization, which will augment Abbott's drug-coated stent programs. Abbott’s drug-coated stent compound is an internally developed rapamycin analogue, a proprietary anti-proliferative agent that has demonstrated encouraging results in preclinical studies. Through the acquisition, Abbott also assumes worldwide commercial rights for all potential drug-coated stent products in Biocompatibles’ pipeline and strengthens its strategic direction over these programs. Abbott currently markets Biocompatibles’ BiodivYsio line in the United States, including the BiodivYsio SV OTW, designed for use in small vessels; the BiodivYsio AS OTW, designed for added support; and the recently approved BiodivYsio OC OTW, designed for optimized conformability. All BiodivYsio products offer the added benefit of PC Technology. Abbott will also acquire the rights to Biocompatibles' proprietary phosphorylcholine (PC) coating technology for use on certain devices in the fields of interventional cardiology, interventional radiology and interventional neuroradiology. PC Technology is a polymer copy of the outside surface of a red blood cell, which mimics the structure of the natural cell membrane. The PC coating is designed to reduce the body's response to implanted devices. Preclinical studies also suggest that the PC coating can act as a versatile, biologically inert, drug-eluting vehicle. Spectranetics Augments LACI Trial Product Line The Spectranetics Corporation has received approval from the Food and Drug Administration (FDA) to add three new catheters to its LACI (Laser Angioplasty for Critical Limb Ischemia) trial, which treats circulatory problems to the lower leg. The new Extreme II Peripheral Excimer Laser Catheters are constructed with features specifically designed for treating the legs, and are available to LACI investigators with 2.0-mm, 2.3-mm and 2.5-mm diameter tips. These catheters have a thicker and stiffer outer tubing than current catheters used in the LACI trial, and the glass fibers within them are wound into a spiral, making the catheter tip more flexible. The combined result is a more pushable catheter that many doctors prefer for maneuvering around curves. The Extreme II catheters also have lasing parameters of ten seconds on and five seconds off, decreasing procedure time compared with previous models (which have lasing parameters of five seconds on and ten seconds off). Joseph A. Largey, president and chief executive officer of Spectranetics, commented: We continue to anticipate FDA approval of LACI in the second half of 2003. The design changes we made were the result of consultations with European doctors who have performed thousands of laser atherectomy procedures in the legs since regulatory approval was received in Europe in November of 1996. They have asked for these design changes in order to facilitate threading the catheter from the opposite leg over the pelvic region and then down to the treatment site, which is the typical approach when clearing blockages in the legs. Spectranetics’ CVX-300 excimer laser is the only system approved by the Food and Drug Administration (FDA) for multiple cardiovascular procedures, including coronary atherectomy and the removal of problematic pacemaker and defibrillator leads. The company is currently conducting two investigational trials designed to obtain FDA approval to market products in the United States for additional applications. The LACI (Laser Angioplasty for Critical Ischemia) trial tests laser atherectomy to improve circulation to the lower leg. Guidant Defibrillator Study Also Expected to Help Competition Guidant Corp.’s successful heart-device study is expected to boost sales of its of implantable cardiac defibrillators, but its competitors will also reap benefits. Guidant got a publicity windfall from its MADIT II study results. The 1,232-patient study showed that heart-attack survivors fitted with implantable cardiac defibrillators (ICDs), had a 31% lower incidence of mortality than heart- attack patients treated conventionally. That was good news for Guidant, and also for ICD manufacturers Medtronic Inc. and St. Jude Medical Inc. Indeed, St. Jude, the smallest player of the three in ICDs, may reap the most if use expands, according to one industry watcher. Indianapolis-based Guidant has about a 36% share of the $1.7 billion ICD market. St. Jude has an 11% share while Medtronic holds 48%, said Matt Dodds, analyst with SG Cowen. Just how much the companies will benefit remains to be seen, with much depending on whether the Centers for Medicare and Medicaid Services agree to add the proposed new use of ICDs to their coverage. Some analysts are already talking about possible improved performance for ICD companies and increasing their projections for growth in ICD sales. Guidant is seeking Food and Drug Administration approval to expand the labeling of ICDs to allow them to be used for patients who have had prior heart attacks and impaired cardiac function but no obvious symptoms of an irregular heart beat. Currently, patients must undergo an invasive test to see if an irregular heart beat can be induced. That requirement has kept the number of ICD recipients relatively low. IntraCoil Receives FDA Approval Sulzer Intratherapeutics Inc.’s IntraCoil self expanding peripheral stent has received FDA approval for vascular use. The stent is for use in patients with atherosclerotic occlusive disease of femoral and popliteal arteries. The IntraCoil is the first stent approved by the FDA for use in these vascular areas, plus the first non-coronary vascular stent to be approved for use as a primary treatment. In a clinical trial that included over 265 patients, the IntraCoil stent was shown to be safe and effective. Nine months after receiving an IntraCoil stent, 86 percent of the patients' treated lesions required no further intervention. The Medicines Company Signs Collaboration for ANGIOMAX in Europe, Including Russia/CIS The Medicines Company announced a collaboration with Nycomed Danmark A/S as the exclusive distributor of ANGIOMAX® (bivalirudin) in 35 countries. The agreement includes 12 countries in the European Union and 23 other countries. Nycomed will exclusively market and distribute ANGIOMAX within the territory, with The Medicines Company and Nycomed sharing ANGIOMAX sales revenue. The Medicines Company will exclusively supply ANGIOMAX finished goods. Nycomed will pay an initial distributor fee to The Medicines Company of $1.5 million with up to $2.5 million in additional milestones based on regulatory approval in Europe. In addition, Nycomed will make a $1 million equity investment in The Medicines Company. The Medicines Company and Nycomed will work together to achieve regulatory approval in the countries covered by the agreement and share costs of clinical trials used to extend indications in Europe beyond coronary angioplasty. We estimate that more than 400,000 angioplasty procedures will be performed in Europe this year and the number is expected to grow by more than 10% per year, noted Clive Meanwell, MD, PhD, Executive Chairman of The Medicines Company. TransVascular, Inc. Receives 510(k) Clearance from FDA TransVascular, Inc., has received 510(k) clearance from the U.S. FDA to commercially market the CrossPoint® TransAccess® catheter in the United States. The CrossPoint catheter is a dual lumen catheter designed to facilitate the placement and positioning of catheters within the peripheral vasculature. St. Jude Medical Announces Launch of the Ultimum Line of Introducers St. Jude Medical, Inc. announced the launch of the Ultimum family of hemostasis introducers. The new Ultimum introducers combine proprietary materials and unique manufacturing processes to provide outstanding insertion performance into the vasculature. The introducer also features a more versatile valve, enabling it to be used in a wider range of clinical procedures. Ultimum introducers were designed to provide minimal risk of vessel access complications, even in patients with scar tissue, a rapidly growing population of patients. With a dual-layer sheath cannula and new dilator configuration, Ultimum introducers provide superior insertion performance for maximum patient comfort. The new valve design provides optimal catheter feel and maneuverability while maintaining hemostasis on guidewires as small as .014 inches which allows the Ultimum introducer platform to be used in both cardiology and endovascular procedures. Guidant Licenses Novartis Drug for Stent Coating Guidant Corp. has licensed their Novartis AG's experimental drug everolimus for use as a coating on stents. Everolimus is an experimental drug in the same family as rapamycin, a class of immune-suppressing drugs that has shown promise in stents being developed by other companies. Guidant said it licensed the drug, which Novartis can still license to another company, based on data from 28-day animal trials. Guidant recently completed enrollment in a U.S. trial of its paclitaxel-coated stents and expects to have data from the trial by the end of this year. Pending regulatory approvals, the company said it expects to launch clinical trials of everolimus-coated stents near the end of the year. Before human trials can be launched, the process for loading the drug onto the stent has to be fine-tuned and dosage and release rates have to be determined, but the drug does not have to be approved by regulators. Novartis will provide everolimus to Guidant, supply data to support Guidant filings with regulatory agencies, and receive milestone payments and a royalty on sales of Guidant products utilizing the drug. Cellular Link Between Sleep Apnea and Atherosclerosis Reported Sleep apnea, a disorder characterized by the temporary cessation of breathing during sleep, displays the same cellular and biochemical changes that are found in atherosclerosis, a disease in which the walls of the arteries thicken, harden, and lose elasticity, resulting in impaired blood circulation, Israeli researchers announced. The study explains why those who suffer from sleep apnea which affects as many as 18 million people in the United States alone, particularly men over age 35 also have cardiovascular problems. The study was led by biochemist Lena Lavie of the Faculty of Medicine at the Technion-Israel Institute of Technology. We found that white blood cells of sleep apnea patients show a large increase in the amount of adhesion molecules that appear on the surface of the cells. These molecules are responsible for the atherogenic processes that thicken artery walls, said Lavie. Lavie headed the study with colleagues Larissa Dyugovskaya and Peretz Lavie. We also saw these white blood cells produced more free radicals, which damage the endothelial cells lining the vessel walls, which, in turn, play a crucial role in maintaining healthy blood vessels, and therefore also contribute to the formation of atherosclerosis. Dr. David White, director of the Sleep Disorders Program at Brigham and Women’s Hospital in Boston and associate professor of medicine at Harvard Medical School, praised the study. This study is an important step forward because the Technion researchers have put together the components needed to explain at least some of the predisposition of apnea patients to vascular disease at the cellular level, White said. There are good data indicating that obstructive sleep apnea leads to adverse cardiovascular outcomes including stroke, congestive heart failure and probably myocardial infarction. To examine the clinical significance of the changes in apnea sufferers’ white blood cells, Lavie’s team added white blood cells from sleep apnea patients to a medium containing cultured human endothelial cells, and studied the interactions between the two types of cells. After one hour, the white blood cells attached themselves firmly to the endothelial cells in the medium. Lavie attributed this to an abundance of adhesion molecules. When white blood cells of normal controls were added to the medium, the researchers did not find comparable changes. They also found that there was no increase in the number of adhesion molecules on the white blood cells of sleep apnea sufferers who were effectively treated with continuous positive air pressure, or CPAP, which delivers air into patients’ airways through specially designed nasal masks. If the firm binding of white blood cells to endothelial cells in the test tube is what happens in the blood of sleep apnea patients every night, then this may be significant evidence that sleep apnea is associated with an active process of atherosclerosis that inflicts damage on the endothelial cells and may lead to increased risk for cardiovascular diseases, Lavie explained. The next step, she said, is to examine whether effective treatment of sleep apnea can abort or even reverse this process and thereby reduce the risk of cardiovascular diseases in sleep apnea patients. Phase II Trial for Cardioprotective Drug Under Way Patient enrollment has commenced in Medicure Inc.’s (Winnipeg, Manitoba, Canada) multi-center Phase II clinical trial to evaluate the cardioprotective effect of its drug MC-1 against potential damage caused by ischemia and ischemic reperfusion frequently experienced by high risk heart disease patients undergoing angioplasty. According to the American Heart Association some 686,000 angioplasty procedures were carried out in the United States alone in the year 2000. The Phase II trial is a placebo controlled single blind feasibility study called MEND-1 for MC-1 to Eliminate Necrosis and Damage. The study will enroll up to 100 high-risk patients scheduled for elective percutaneous coronary intervention by angioplasty at sites in the U.S. and Canada. The trial will be managed by the Duke Clinical Research Institute (DCRI) in Durham, N.C. The primary endpoint of the trial is infarct size (area of the heart that is damaged) during the procedure as determined by the release of the cardiac enzyme CK-MB over 24 hours following angioplasty. Secondary endpoints include periprocedural myocardial ischemia over 24 hours measured by continuous ST-segment EKG monitoring and the composite clinical endpoint of death, nonfatal myocardial infarct, new or worsening heart failure, or recurrent ischemia at 30 days following the procedure. Full enrollment in the study is scheduled to be achieved before year-end. In addition to treatment of angioplasty patients, preclinical research indicates the potential for MC-1 to reduce damage from other related ischemic conditions, such as heart attacks, coronary bypass surgery (CABG) and stroke. The ongoing MEND-1 trial will add support to Medicure’s clinical and preclinical development efforts being directed at these other important medical needs. Researchers Say Statins May Prevent Damage by Alzheimer’s Disease Statins block damage by an Alzheimer’s-associated protein in neurons and blood vessels, said researchers at the University of South Florida. The researchers examined the biochemical effects of statins in reducing damage from Alzheimer’s disease. Statins block the vasoconstrictive effects of the A-beta protein a critical protein involved in Alzheimer’s disease pathology, said Daniel Paris, first author of the study and an assistant professor at the USF Roskamp Institute. These drugs appear to have anti-inflammatory properties, independent of their benefit in lowering cholesterol, that may help protect against dementia. Recently, the risk of developing Alzheimer's disease has been shown to be reduced in populations treated with statins, although the reason is unclear. Other studies indicate that high cholesterol or other cardiovascular conditions also increase the risk for Alzheimer’s disease. The Roskamp researchers, searching for clues to understand the preventive action of statins, were struck by the similar effects of cholesterol and the A-beta protein (AB) in blood vessels. Both compounds promote the constriction of blood vessels through a similar mechanism. They hypothesized that the same drugs that inhibit the production of cholesterol might affect AB’s stimulation of inflammatory substances that result in blood vessel constriction. The researchers studied the effects of two statins most commonly used to treat high cholesterol mevinolin (lovastatin) and mevastatin (compactin). AB appears to be toxic to human neuronal cells cultured in the laboratory. But, when these same neurons were treated with mevastatin, the neurotoxicity normally induced by AB was prevented, the researchers found. The researchers also looked at the effect of both statins mevinolin and mevastatin on the constriction of laboratory-prepared aortic arteries from rats. They observed that the statins opposed the AB protein’s propensity to cause blood vessels to constrict. Furthermore, Paris said, this prevention of vessel constriction appears to be due to the general anti-inflammatory properties of the statins, and is unrelated to the biochemical mechanism used by the drugs to reduce cholesterol production. That is, statins may protect the vessels by opposing inflammatory substances triggered by AB. The Roskamp researchers are further testing the effectiveness of statins to prevent or slow the progression of Alzheimer’s disease in a mouse model for the neurodegenerative disease. Enrollment Starts for Driver Coronary Stent System Medtronic Inc. has begun enrollment in a clinical trial designed to determine the safety and efficacy of its new Driver Coronary Stent System, formerly known as the S8. The De Novo and Restenotic Registry clinical trial will study the long-term outcomes for patients treated with the Driver coronary stent system. The study, headed by Dr. Michael H. Sketch Jr. of Duke University Medical Center, will enroll about 300 patients at 20 clinical sites throughout the U.S. The study is designed to show the safety and efficacy of the Driver stent system in treating de novo and restenotic lesions in coronary vessels with a diameter of 3.0 “ 4.0 mm. Six-month angiographic data will be collected from the first 100 patients enrolled in the study. Medtronic’s Driver coronary stent is made of a cobalt-based alloy that is designed to be stronger and denser than the conventional stainless steel used in other stents. This new alloy is also designed to allow for thinner struts, resulting in a lower profile and better deliverability without compromising radial strength and visibility. The Driver incorporates the best of the S7 coronary stent system, including modular design and new balloon material. Study Shows Meridian ECG Detects Heart Attacks Missed by 12-lead ECG Meridian Medical Technologies Inc. (Columbia, MD) announced that results of a new multi-center clinical study with its Prime ECG electrocardiac mapping system demonstrate the accuracy of the new device in the early diagnosis of heart attacks that are frequently missed by conventional ECG systems. Meridian recently received FDA clearance to market the Prime ECG system. The company said the system has been studied in more than 4,000 patients in the United States and Europe. The study measured the Prime ECG system’s ability to detect acute ST-elevation MI (STEMI) compared to a traditional 12-lead ECG system in a multi-center trial involving 647 patients with chest pain. Investigators found that the Prime ECG system achieved a sensitivity of 93 percent for STEMI, a 63 percent improvement over a sensitivity of 57 percent with the 12-lead ECG. Specificity was 95 percent for both systems, the company said. Positive troponin tests were used as the gold standard for comparison. Meridian said the study also showed the Prime ECG system to be especially effective in identifying posterior and right ventricular MIs. Prime was able to increase detection of both posterior and right ventricular involvement compared to the 12-lead ECG by 36 percent and 33 percent respectively. The Prime ECG system incorporates 80 leads 64 anterior (chest) leads and 16 posterior (back) leads compared with only 12 anterior leads used with traditional ECG devices. The new system features an easy-to-apply disposable electrode vest with an increased diagnostic detection area encompassing the entire torso to obtain a more complete view of the heart’s electrical activity. Proprietary computer software rapidly processes the heart signals to create full-color, multidimensional, diagnostic images designed to be more revealing and easily interpreted than a traditional ECG pattern. Physician Practices Offered Solution to Assess and Reach HIPAA Compliance In response to the needs of small physician practices to comply with the HIPAA privacy and security requirements without expensive outside consultants or technology, HealthFlash, a software provider of compliance and accreditation software, announced the availability of HIPAAdocs, a new set of Web-based applications to guide small offices through the needed changes to meet HIPAA compliance. HIPAA privacy and security regulations requires significant planning and work on the part of virtually every healthcare practitioner, regardless of size, to comply with the rigorous requirements for safeguarding protected health information by April 2003. HealthFlash currently provides powerful software to manage compliance and accreditation in hospitals and managed healthcare organizations. It is now offering HIPAAdocs to evaluate the impact of the privacy & security regulations on small individual practices, and guide an office through the needed changes to meet HIPAA compliance. HIPAAdocs offers online training for privacy officer and staff, complying with one of the HIPAA requirements. Bringing content from national-level HIPAA experts to the small organization, HIPAAdocs averages less than $300 per physician and is a cost-effective Web application that allows practices to assess, achieve and maintain HIPAA compliance. Designed to work over the Internet on a simple dial-up modem connection, the program requires no software license or installation or additional telecommunications infrastructure to implement. The product’s self-guided wizards and Internet interface makes it more user friendly than enterprise-wide software applications. Doctors and their staff can use HIPAAdocs to become and remain compliant in a format that pre-supposes no special knowledge of HIPAA. For more information, visit www.healthflash.com Noninvasive Imaging Valuable in Heart Failure Treatment The results of a study demonstrate that noninvasive imaging can accurately identify heart tissue with preserved blood flow and impaired function, according to Bristol-Myers Squibb Medical Imaging. Hibernating myocardium is an important marker for treating patients with heart failure due to coronary artery disease (CAD). The study results suggest that medical therapy may be an effective alternative to more invasive treatments currently used to revive hibernating tissue. In the randomized, double-blind study called CHRISTMAS (Carvedilol Hibernation Reversible Ischemia Trial; Marker of Success), cardiac perfusion imaging with Cardiolite and echocardiography were used to identify hibernating myocardium. Cardiolite is the only FDA-approved imaging agent that noninvasively measures heart function and perfusion. Researchers were interested in determining if the amount of hibernating tissue correlated with improvement in the heart’s ejection fraction-a measure of the amount of blood pumped during each heartbeat-when treated with the beta blocker carvedilol. The data were based on the six month evaluation of 408 patients, mostly male with a mean age of 62, with chronic heart failure and known CAD. As a result of the noninvasive assessments with Cardiolite and echocardiography, patients were classified as hibernators or nonhibernators and were separated into two groups of similar size and then randomized to receive carvedilol or a placebo. Both the hibernating and nonhibernating groups taking carvedilol showed improvement in ejection fraction. However, patients with a lower ejection fraction but a larger amount of hibernating tissue showed the most improvement in heart function. The study also showed that clinical features such as diabetes, angina, and pre-treatment ejection fraction did not help identify patients with hibernating tissue. The study findings point to the importance of screening heart failure patients, like the ones in the study, with Cardiolite and echocardiography to identify the presence of hibernating tissue and to selectively treat those patients. For more information, visit www.cardiolite.com. Cordis' CYPHER Sirolimus-eluting Stent Receives CE Mark Approval Cordis Corporation, a Johnson & Johnson company, reported its new CYPHER Sirolimus- eluting Stent received CE Mark approval in Europe for treatment of de novo coronary artery lesions (less than or equal to 30 mm in length) in native coronary arteries with reference diameters ranging from 2.25 to 5.0 mm. The CYPHER Sirolimus-eluting Stent has continued to demonstrate very positive results throughout its clinical trials in Europe and Latin America, said Robert W. Croce, Johnson & Johnson Company Group Chairman responsible for the Cordis franchise. We are extremely pleased that the CYPHER Stent can now be made available to patients throughout Europe. It is gratifying that we had strong, comprehensive long-term data to present to the BSI, Croce added. In fulfillment of the requirement for clinical data, Cordis submitted the 12-month results of RAVEL, a large-scale, randomized, double-blind, controlled clinical trial involving 238 patients from 19 hospitals across Europe and Latin America. The study was powered to detect a significant difference in a clinically meaningful endpoint at 6 months. Data presented for CE Mark approval included 1-year follow-up with a significantly lower MACE rate compared with that of the control, a subacute thrombosis (SAT) rate comparable to that of the control, and a target lesion revascularization (TLR) rate significantly lower than that of the control. Cordis researchers chose sirolimus for its cytostatic, rather than cytotoxic, properties. The CYPHER Sirolimus-eluting Stent is designed to inhibit proliferating cells, not destroy them. Cordis' clinical research program in drug-eluting stents involves 18 separate studies, making it the most extensive drug-eluting stent research program in the industry. To date, nearly 1,600 patients have been enrolled in CYPHER Sirolimus-eluting Stent clinical studies. More than 1,000 of the 1,600 have received the CYPHER Stent. GlaxoSmithKline and Texas Biotechnology Receive FDA Approval for New Indication of Argatroban Texas Biotechnology Corporation and GlaxoSmithKline announced that the U.S. FDA has approved the supplemental New Drug Application (sNDA) for the new use of Argatroban as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia (HIT) undergoing percutaneous coronary interventions (PCI). Argatroban is currently approved for the prophylaxis or treatment of thrombosis in patients with HIT. Argatroban, which was co-developed by Texas Biotechnology and GlaxoSmithKline, is currently marketed in the U.S. by GlaxoSmithKline. Bruce D. Given, M.D., President and CEO of Texas Biotechnology stated, This second approval from the FDA demonstrates both our commitment and our ability to expand the use of Argatroban beyond its initial indication and optimize its use in a number of hospital based cardiovascular indications. Dr. Given added, Further evidence of our commitment to find new, beneficial uses is reflected in our ongoing Phase II clinical trials with Argatroban in ischemic stroke and in the overall PCI market. We are very pleased to see this additional indication in the Argatroban label. Argatroban saves lives for those patients at risk and who may suffer HIT consequences, stated Kevin Lokay, Vice President of Oncology at GlaxoSmithKline. This approval is one more step forward in our commitment to improving the awareness and treatment of HIT. According to Dr. William Matthai, Clinical Associate Professor of Medicine, University of Pennsylvania Medical School, Division of Cardiology, The clinical importance of HIT is now recognized by most physicians, which is further supported now that there is an agent approved for use during angioplasty in patients with or at risk for HIT.